hsCRP Clinical Inflammation Marker for Human Bisphenol A Food Contamination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-25

Study Completion Date

2019-12-10

Brief Summary

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Dietary intervention studies thus far have failed to be replicable or causal.This is particularly relevant regarding plastic-derived chemicals (PDCs),This first-of-a-kind dietary intervention study explores a potential causal relationship between human serum levels of BPA and High-Sensitivity C-Reactive Protein (hsCRP)

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Detailed Description

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Dietary intervention studies thus far have failed to be replicable or causal. The results, therefore, have failed to provide clinicians and the general public with consistent and useful information on which to base reliable food-related health decisions. This is particularly relevant regarding plastic-derived chemicals (PDCs), such as Bisphenol A, now that the federal CLARITY-BPA program has failed to achieve scientific consensus. Investigators propose a novel human dietary protocol that is both replicable and causal, based upon BPA's demonstrated inflammatory effects in humans. This first-of-a-kind dietary intervention study explores a potential causal relationship between human serum levels of BPA and High-Sensitivity C-Reactive Protein (hsCRP), a proven clinical indicator of inflammation. Investigators used the equivalent of a USDA-defined "typical diet" followed by a PDC-reduced diet to compare blood levels of hsCRP. This proof-of-concept investigation is the first to use an easily accessible, medically-accepted clinical laboratory test to directly measure human health effects of PDC reduction. Unexpected new complications discovered during the investigation indicate that these results may yet be inconclusive for direct causal relationship. However, the novel lessons and techniques developed as a result of those discoveries offer further specific and improved methods and best practices that can enable future dietary interventions to produce replicable, causal results.

Conditions

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Inflammation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Diet Before

Typical diet contaminated with Bisphenol A. Patient assigned to this arm will consume a typical American diet as defined by USDA.

Group Type ACTIVE_COMPARATOR

hsCRP serum measurement of inflammation

Intervention Type DIAGNOSTIC_TEST

hsCRP inflammation change as result of non-contaminated diet

Diet After

Bisphenol A reduced. Patient assigned to this arm will consume a diet analogous to atypical American diet as defined by USDA, but with known Bisphenol A sources reduced or eliminated.

Group Type ACTIVE_COMPARATOR

hsCRP serum measurement of inflammation

Intervention Type DIAGNOSTIC_TEST

hsCRP inflammation change as result of non-contaminated diet

Interventions

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hsCRP serum measurement of inflammation

hsCRP inflammation change as result of non-contaminated diet

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Overall good health
* hsCRP below 10
* Standard health review blood panel normal
* BMI less than 25
* % body fat less than 23%
* Resident of North San Francisco Bay area
* Willing to eat 100% of all foods and beverages provided.
* No food allergies
* Not taking prescription medications or supplements including daily aspirin.
* Written unformed consent

Exclusion Criteria

* Subject in poor health
* hsCRP above 10
* Standard health review blood panel beyond minimum or maximum limits for any measurement.
* Taking taking prescription medications or supplements including daily aspirin.
* Any evidence of inflammation-linked disease or syndrome including cardiovascular, metabolic syndrome, Type 2 Diabetes, insulin resistance, obesity, auto-immune disease, depression, or other neurological or behavioral disorders.

Minimum Eligible Age

60 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes